LETROZOLE MEVON TABLETS 2.5MG [SIN13916P]

Product Info

LETROZOLE MEVON TABLETS 2.5MG

[SIN13916P]

4.1 Therapeutic indications

Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer.

Extended adjuvant treatment of early breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy.

First-line treatment in postmenopausal women with advanced hormone-dependent breast cancer.

Treatment of advance breast cancer in women with natural or artificially induced postmenopausal status, who have previously been treated with antioestrogens.

4.2 Posology and method of administration

Adults and elderly patients
The recommended dose of Letrozole is 2.5 mg once daily.

In the extended adjuvant setting, the optimal treatment duration with Letrozole is not known. The planned duration of treatment in the study was 5 years. However at the time of the analysis, the median treatment duration was 24 months. 25% of patients were treated for at least 3 years and less than 1% of patients were treated for the planned duration of 5 years. The median duration of follow up was 28 months.
Treatment should be discontinued at tumour relapse. In patients with metastatic disease, treatment with Letrozole should continue until tumour progression is evident. No dose adjustment is required for elderly patients.

In the adjuvant setting, the optimal duration of treatment with letrozole is unknown. The planned duration of treatment in the study is 5 years. However, at the time of analysis, the median duration of treatment was 24 months, median duration of follow-up was 26 months, and 16% of the patients have been treated for 5 years. Treatment should be discontinued at relapse.

Children
Not applicable.

Patients with hepatic and/or renal impairment
No dosage adjustment is required for patients with hepatic impairment or renal impairment (creatinine clearance ≥10 mL/min.). However, the dose of Letrozole in patients with cirrhosis and severe hepatic dysfunction (Child-Pugh score C) should be reduced by 50% (see PHARMACOKINETICS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The recommended dose of letrozole for such patients is 2.5mg administered every other day. Patients with severe hepatic impairment should be kept under close supervision (see section PHARMACOKINETICS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients. Pre-menopausal endocrine status; pregnancy and lactation (see section 5.3 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).